510(k) · Cleared
ClearedQMS Digoxin Reagent System on the Abbott Aeroset System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn · KXT Enzyme Immunoassay, Digoxin
Cleared on Oct 24, 2002 after a 41-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Oct 24, 2002
- Review
- 41 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK023058 QMS Digoxin Reagent System on the Abbott Aeroset SystemSeradyn · 2002
- Descendant · cites it directly · 0 of its ownK082953 Architect Idigoxin and Architect Idigoxin Calibrators, Models…Biokit, S.A. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082953Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01Biokit, S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023058 | QMS Digoxin Reagent System on the Abbott Aeroset System | Seradyn | 2002 | — |
| +1 | K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and… | Biokit, S.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXT device
- #1 K193397 ADVIA Centaur® Digoxin assayscore 1.7 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K953239 | FDA’s K953239 is Boehringer Mannheim/Hitachi 917 Analyzer Our reading of the summary gave K953239, FDA’s number for Boehringer Mannheim/Hitachi 917 Analyzer (Boehringer Mannheim Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Roche Tina-quant Digoxin”. Kept off the family tree. | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082953 (Biokit, S.A., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXT
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KXT
Too few KXT 510(k)s in any year since 2007 to give a median.
Recalls per year · KXT
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXT
7in 2024
MAUDE reports naming product code KXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 3 | 310 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SERADYN QMS DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET System. Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low…
Read the full statement (178 words)
The SERADYN QMS DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET System.
Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Coupled with the narrow therapeutic range is a marked patient variability in response to the same dosage of drug, often resulting in unpredictable serum drug levels. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. It may not be immediately apparent whether the patient has been under or overdosed.
Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023058: QMS Digoxin Reagent System on the Abbott Aeroset System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023058
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026